A Study to Evaluate the Efficacy of Amniotic Suspension Allograft in Patients With Osteoarthritis of the Knee

• Status: Recruiting
• Trial end date: 2026-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is being conducted to evaluate the efficacy and safety of ASA compared to placebo in the management of osteoarthritis (OA) symptoms of the knee.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Organogenesis

Criteria

Inclusion Criteria:

• Males or females 18 years of age or older

• Diagnosis of OA of the index knee by a combination of clinical and radiographic findings.

• OA of the index knee with Kellgren and Lawrence radiographic classification (Grades 2-4 inclusive),

• Patients who have failed to adequately respond for at least 6 months to at least two osteoarthritis therapies within the last 12 months

• Overall index knee pain score above minimum required WOMAC Pain scale.

• Body mass index < 40 kg/m2

• Using birth control, sterile or post-menopausal.

• Able to understand and provide written informed consent

Exclusion Criteria:

• Kellgren and Lawrence radiographic grade 1 OA of the knee

• Use of pain medication less than 5 days before the baseline visit

• Regular use of anticoagulants

• Symptoms that could indicate meniscal displacement or an IA loose body.

• Corticosteroid injection into the index knee within 3 months prior to screening.

• Viscosupplement or any other autologous or allogeneic product into the index knee within 6 months prior to screening.

• Patients with known hypersensitivity reactions to ASA or any of its constituents.

• Knee surgery on the index knee within 12 months prior to screening and/or planned knee surgery during the study

• Knee surgery on the contralateral knee within 6 months prior to screening and/or planned knee surgery during the study

• Acute index knee trauma within 3 months prior to screening

• Knee effusion requiring aspiration of the index or contralateral knee within 3 months prior to screening.

• Contralateral knee pain above limits defined in the protocol

• Current therapy with any immunosuppressive therapy or medical conditions likely to require systemic steroids during the study.

• Any active or systemic infection including infection of the index knee joint or breakdown or disease of the index knee skin/soft tissues.

• Clinically significant intercurrent illness, medical condition, non-knee pain, or medical history that would jeopardize patient safety, limit participation, or compromise interpretation of data derived from the patient

• Active alcohol or substance use disorder, or any other reason that would make it unlikely that the patient will comply with study procedures

• Females who are pregnant or lactating

• Participation in another clinical trial within the 30 days (or 5 half-lives of the investigational compound, whichever is longer) before screening.